Primary Outcome Measures Objective Response Rate (ORR) defined as the percentage of participants who achieve a best overall response of complete response or partial response assessed according to mRECIST v1.1 for assessment of response in malignant pleural mesothelioma. Up to 36 months Secondary Outcome Measures Progression Free Survival (PFS) defined[…]
Upcoming
Neoadjuvant Durvalumab and Tremelimumab With and Without Chemotherapy for Mesothelioma
Primary Objective The primary objective is to test whether the combination of platinum-based chemotherapy and pemetrexed with durvalumab / tremelimumab or durvalumab / tremelimumab alone improves recurrence-free survival for patients with resectable MPM compared to historical, published data for surgery with chemotherapy. Secondary Objective The secondary objectives are to determine[…]
Integration of the PD-L1 Inhibitor Atezolizumab and WT1/DC Vaccination Into Platinum/Pemetrexed-based First-line Treatment for Epithelioid Malignant Pleural Mesothelioma (Immuno-MESODEC)
Primary Outcome Measures Proportion of patients that experienced (S)AEs possibly, probably or definitely related to pemetrexed and/or cisplatin/carboplatin and/or atezolizumab and/or WT1/DC vaccination [ Time Frame: through study completion, an average of 2 years ] The relationship of an AE to the investigational agents will be determined by the Investigator as either related or[…]
Safety and Tolerability of TNG462 in Patients With MTAP-deleted Solid Tumors
Primary Outcome Measures Phase 1 Maximum Tolerated Dose [ Time Frame: 28 days ] To determine the maximum tolerated dose (MTD) of TNG462 Phase 1 Dosing Schedule [ Time Frame: 28 days ] To determine the dosing schedule of TNG462 Phase 2 Anti-neoplastic Activity [ Time Frame: 16 weeks ] To assess anti-neoplastic activity of TNG462 in patients with MTAP-deleted advanced solid[…]
NUC-3373 in Combination With Other Agents in Patients With Advanced Solid Tumours
Primary Outcome Measures Number of patients tolerating dose levels (maximum tolerated dose; MTD) in each of the combinations [ Time Frame: Assessed from baseline to 30 days after last dose of study drug ] MTD of NUC-3373 in each of the combinations in each patient Number of patients reporting treatment-emergent adverse events (TEAEs) in[…]
Study of CAR.70-engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Chemotherapy for the Management of Advanced Renal Cell Carcinoma, Mesothelioma and Osteosarcoma
Primary Outcome Measures Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 [ Time Frame: through study completion; an average of 1 year. ] Inclusion Criteria Signed consent to long-term follow-up on protocol PA17-0483 Patients with advanced clear cell renal cell carcinoma,[…]
SynKIR-110 for Mesothelin Expressing Ovarian Cancer, Cholangiocarcinoma or Mesothelioma
Primary Outcome Measures Safety and feasibility of SynKIR-110 [ Time Frame: Date of enrollment through date of last patient visit, up to 36 months. ] • The incidence, frequency, and severity of TEAEs, incidence of AEs related to native mesothelin-expressing tissues, • Incidence of CRS and/or neurologic toxicity Secondary Outcome Measures Define the MTD[…]
A Phase 1 Study of PRT3645 in Participants With Select Advanced or Metastatic Solid Tumors
Primary Outcome Measures Dose limiting toxicity (DLT) of PRT3645 [ Time Frame: Baseline through Day 28 ] Dose limiting toxicity will be evaluated over the 28-day observation period Safety and tolerability of PRT3645: AEs, CTCAE Assessments [ Time Frame: Baseline through approximately 2 years ] Safety and tolerability will be evaluated by incidence of DLTs, laboratory measurements, severity[…]
TTFields in General Routine Clinical Care in Patients With Pleural Mesothelioma Study (TIGER Meso)
Primary Outcome Measures Time from diagnosis of pleural mesothelioma to death of any cause as median overall survival time. [ Time Frame: 54 Months ] Secondary Outcome Measures Number of TTFields treatment-related SAEs, as assessed by the CEC, within total observation period, standardized to average annual incidences. [ Time Frame: 3 years + 18 months follow up ][…]
AMT-151 in Patients With Selected Advanced Solid Tumours
Primary Outcome Measures Recommended Phase 2 Dose (RP2D) [ Time Frame: Up to 24 months ] The RP2D will be determined using dose limiting toxicities (DLTs) and all other available study data Maximum Tolerated Dose (MTD) [ Time Frame: Up to 24 months ] The MTD will be determined using DLTs Incidence of Adverse Events [ Time Frame: Up to 24[…]
